"...changes requiring an amendment to an IND application may include:
Any increase in drug dosage or duration of exposure of individual subjects to the drug beyond that described in the current protocol, or any significant increase in the number of subjects under study."
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
email@example.com+1 301 770 2920
JoinMy RAPS DashboardLearn More